Propolis in Reducing Dentin Hypersensitivity

Universidade Federal do Para

Status

Completed

Conditions

Dentin Sensitivity

Treatments

Other: Propolis 15%

Other: Placebo

Other: Propolis 10%

Study type

Interventional

Funder types

Other

Identifiers

NCT05083052

UFPa - 0011

Details and patient eligibility

About

Objective: This randomized, double-blind, parallel, placebo-controlled clinical trial aims to evaluate the effect of propolis with two distinct concentrations (10% and 15%), and the impact on volunteers' quality of life.

Materials and methods: Volunteers meeting the inclusion and exclusion criteria will be randomized and allocated into three groups: Group 1- placebo - toothpaste without active ingredient, Group 2- toothpaste with 10% propolis and Group 3. - toothpaste with 15% propolis. Number of teeth will be used as sample unit, totaling 22 teeth per group. Volunteers will receive oral hygiene instruction with guidance to brush their teeth three times a day with toothpaste corresponding to the groups in which they will be allocated for 30 days. The evaluation of dentin hypersensitivity will be performed with three (3) evaluation times: baseline (immediately before the beginning of treatment), 15 and 30 days, through tactile and evaporative stimuli, using the visual analog scale (VAS). The self-reported evaluation of the volunteers will be done through a questionnaire before the beginning and after one month with the completion of the research to determine the impact of treatment on their quality of life. The data regarding HD in VAS, if present normal distribution, will be used Two-way analysis of variance (ANOVA) with Tukey's post hoc for comparison between treatments. However, if the data show anormal distribution, Friedman to compare the different times in the same group (intra group), and Kruskal Wallis to make the comparison between groups (inter group). To evaluate the QEHD ordinal data, Wilcoxon and Mann-Whitney tests will be used. Bioestat 5.3 (Belém, Pará, Brazil) will be used, considering an alpha level of 5%.

Enrollment

19 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Two to four hypersensitive teeth with a response ≥ 04 on the visual analogue scale (VAS) from 0 to 10, where 0 represents no pain and 10 extreme pain, during the application of tactile (explorer probe) and evaporative (jet air);
Dentinal exposure on the posterior teeth, due to the presence of a shallow non-carious lesion up to 02 mm in depth, according to the Smith & Knight index (measured with a millimeter probe), and / or class I gingival recession according to Miller classification.

Exclusion criteria

Restorations; tooth decay and/or periodontal pockets; dental pulpitis; enamel cracks or fractures on sensitive teeth;
Continuous treatment with anti-inflammatory drugs and/or analgesics or desensitizing treatment induced three months prior to research recruitment data;
Pregnancy or lactation;
Systemic diseases;
Fixed orthodontic appliances;
Occlusal instability.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

19 participants in 3 patient groups, including a placebo group

PLACEBO

Placebo Comparator group

Description:

Carbonato de cálcio: 40,0%, Glicerina: 20,0%, Lauril Sulfato de sódio: 1,2%, Carboximetilcelulose: 2,0%, Goma xantana: 1,0%, Metilparabeno (nipagim): 0,15%, EDTA: 0,5%, Sacarina: 0,1%, Flavorizante: 0,75%, Água deionizada q.s.p - 100mL.

Treatment:

Other: Placebo

PROPOLIS 10%

Experimental group

Description:

Treatment:

Other: Propolis 10%

PROPOLIS 15%

Experimental group

Description:

Treatment:

Other: Propolis 15%